Z-0851-2014Class II

User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software...

Name: Z-0851-2014 User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-10-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-10-07 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex... on 2013-10-07. FDA classified it as Class II and gives the reason as "When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0851-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-07
Posted: 2014-01-28
Terminated: 2014-08-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Cartridge to process the user defined method.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Urgent Medical Device Correction letter dated October 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please use the following actions if using Vista SW Versions 3.5.1 and below to prevent the issue from occurring: 1. When assigning a User Defined (EMPTY) Flex, use the Advanced Inventory Screen per the Operators Guide. 2. Verify that EMPTY Flex is no longer listed in the inventory before proceeding with any testing. 3. If the EMPTY Flex is still listed in the inventory, contact your Siemens Customer Care Center - Technical Solutions for assistance. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Discuss the content of this letter with your Medical Director. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center - Technical Solutions at (800-441-9250) or your local Siemens technical support representative.
Quantity in commerce: 2038
Distribution: USA (nationwide) Distribution including Puerto Rico.
Product codes and lots: Material numbers 10284473, 10488224, 10444801, and 10444802.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0851-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0851-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28

Product code JJE

K051087Class IDimension Vista Integrated SystemDade Behring, Inc. / cleared 2005-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)